Healthcare Industry News: Capsule Endoscopy
News Release - November 19, 2007
Given Imaging Announces Aetna to Cover Capsule Endoscopy of the EsophagusFirst Private Insurance Payer to Cover Procedure for Esophageal Varices
YOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Nov 19, 2007 -- Given Imaging Ltd. (NasdaqGM:GIVN ), the global leader in Capsule Endoscopy, today announced that Aetna, the third-largest U.S. health insurer, has updated its Capsule Endoscopy policy effective November 9, 2007. Under the new guidelines, Aetna will now cover cirrhotic patients for the screening and surveillance of esophageal varices using Capsule Endoscopy of the esophagus. Aetna currently serves 16.6 million medical members. The addition of Aetna's coverage policy now brings the total number of people in the U.S. that have reimbursable access to PillCam® ESO to approximately 30 million.
"We commend Aetna for recognizing PillCam ESO and its role in the evaluation of esophageal varices in cirrhotic patients," said John M. Vierling, M.D., Baylor College of Medicine. "We hope that additional payers will soon recognize the value of this non-invasive procedure to identify patients with varices so that we can use proven prophylatic therapies to reduce the risk of bleeding."
Varices are varicose veins that occur in the esophagus as a result of portal hypertension, which is a complication of cirrhosis. The increased pressure within esophageal varices makes them susceptible to rupture and bleeding. Approximately 360 of every 100,000 Americans have cirrhosis, and gastroesophageal varices are present in 40-60% of these patients.
Physicians seeking additional information can access the updated policy at http://www.aetna.com/cpb/medical/data/500_599/0588.html or can contact Given Imaging's Reimbursement Help Line at 1-888-389-5200.
About PillCam ESO
Cleared by the U.S. Food and Drug Administration in November 2004 to visualize the esophagus in adult patients in a patient-friendly way, physicians can use PillCam ESO to aid in the detection of disorders such as Barrett's esophagus, a potential precursor for esophageal cancer and esophageal varices, which if left untreated, can result in fatal bleeding. PillCam ESO contains imaging devices and light sources at both ends of the capsule that capture up to 14 images per second, a total of 2,600 color images, as it passes down the esophagus in a twenty-minute procedure.
About Given Imaging Ltd.
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the PillCam® Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID® software. Given Imaging has a number of available capsules: the PillCam SB video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 60 other countries; the PillCam ESO video capsule to visualize the esophagus; the Agile(TM) patency capsule to determine the free passage of the PillCam capsule in the GI tract and the PillCam COLON video capsule to visualize the colon that has been cleared for marketing in the European Union, and is pending clearance with the United States Food and Drug Administration. More than 600,000 patients worldwide have benefited from the PillCam Capsule Endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel. It has operating subsidiary companies in the United States, Germany, France, Japan and Australia. For more information, visit http://www.givenimaging.com.
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements may be, but are not necessarily, identified by the use of forward-looking terminology such as "may," "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual events, results, performance, circumstances or achievements of the Company to be materially different from any future events, results, performance, circumstances or achievements expressed or implied by such forward-looking statements. Factors that could cause actual events, results, performance, circumstances or achievements to differ from such forward-looking statements include, but are not limited to, the following: (1) satisfactory results of clinical trials with PillCam Colon (2) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (3) our success in implementing our sales, marketing and manufacturing plans, (4) protection and validity of patents and other intellectual property rights, (5) the impact of currency exchange rates, (6) the effect of competition by other companies, (7) the outcome of future litigation, including patent litigation with Olympus Corporation, (8) the reimbursement policies for our product from healthcare payors, (9) quarterly variations in operating results, (10) the possibility of armed conflict or civil or military unrest in Israel, and (11) other risks and factors disclosed in our filings with the U.S. Securities and Exchange Commission, including, but not limited to, risks and factors identified under such headings as "Risk Factors," "Cautionary Language Regarding Forward-Looking Statements" and "Operating Results and Financial Review and Prospects" in the Company's Annual Report on Form 20-F for the year ended December 31, 2006. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except for the Company's ongoing obligations to disclose material information under the applicable securities laws, it undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.
Source: Given Imaging
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